Novartis: Pragmatic Clinical Trials & RWE Gain Traction

By Ed Miseta, Chief Editor, Clinical Leader

As the head of strategic alliances and customer transactions in U.S. medical affairs for Novartis, Sameer Tandon spends a good deal of time overseeing sourcing and contracting functions. The medical affairs group supports all of the company’s post-market products launched in the U.S. He also has more than 20 years in the pharma industry working in similar roles.

“I enjoy this job because as someone who has spent a good portion of my career working in early phase proof-of-concept trials, I am finally in a position where I get to see the fruits of all those labors,” says Tandon. “This is an area where all of that early work finally manifests itself in marketed products. In this area, I see the end result of all the challenges, partnerships, and trials finally paying off in the form of approved medicines for patients.”

In this Q&A, Tandon shares some of the challenges of his job and what trends will shape the future of the medical affairs group.

Ed Miseta: What does your work day typically look like?

Sameer Tandon: Right now, I am spending a lot of time on good sourcing practices. We handle marketed products, but we also do Phase 3b interventional trials and Phase 4 registry trials to support products that have been recently launched.

Miseta: I heard a lot of talk at DIA this year about real-world evidence. Is that a hot area for Novartis?

Tandon: I am definitely spending a lot of time on real-world evidence and health economic outcomes research as well. When it comes to real-world evidence, it will be a key criteria someday for approval. But right now, there are still a lot of issues that need to be worked out. I believe that is part of the reason so many companies are now performing these pragmatic trials – to broaden and diversify the patient population. The criticism pharma gets is that we perform clinical trials in very controlled spaces. It’s not the real world and there is not much diversity there. I think that is the whole point of getting out there and gathering more real-world evidence from patients.

Miseta: The industry will need to learn more about how this will play out with the FDA. But it seems we will need to take a closer look at how this is going to play out with payers as well. 

Tandon: Absolutely. Reimbursement decisions are most certainly going to be more focused on real-world evidence than the controlled clinical trial data that we have focused on in the past. If insurance companies are going to pay for a new treatment, they will want to understand the benefit provided to the patient population as a whole, not just a subset of the population that may have been included in a clinical trial.

Miseta: Pharma companies have, for years, been outsourcing clinical trials to CROs. Are companies outsourcing these real-world evidence studies as well?   

Tandon: For Novartis, it is all outsourced. Currently, I would say almost 90 percent of what we do in the clinical trial space is outsourced. When we outsource to a provider outside the company, there is a limited group of providers that we tend to use. Right now, I believe there is a push within many companies, including Novartis, to reduce the number of suppliers across all of our key categories. There are a lot of companies out there and a lot of divisions within Novartis. There are times those different divisions will be using different suppliers.  Sometimes those decisions are based on factors such as past performance, quality, therapeutic expertise and geography rather than issues involving pricing. 

Miseta: As someone who works on the procurement side of the house, I’m sure reducing cost is something you think about.

Tandon:  It’s not the only thing I think about, but it’s certainly a concern. If you are working with three or four companies, you might be getting the best deal possible. If you are working with 7,000 suppliers, that is likely not the case. With a smaller number of companies, you are better able to negotiate rate cards and master agreements and get all of the discounts and benefits they provide. That’s something that is simply not possible to do when dealing with a large number of companies.

Of course, there are also two sides to that argument. If you have a smaller number of suppliers on a preferred vendor list, it restricts the amount of innovation you are able to do. For example, there may be a company you want to work with because the people there tend to be very innovative. If that company is not on the short list of companies you can work with, then you lose out on that opportunity. That is both a sourcing and a business challenge, and a constant push and pull that we have to deal. It can certainly create challenges between the business team and the procurement team. 

Miseta: So you want one company that can be a strategic partner, can be innovative, knows your therapeutic area, can deliver quality, and can do it all for a good price. Does that sound about right?

Tandon: Exactly. And we all know how difficult it can be to find that one company that can do it all. For a company to limit itself to just two strategic partners, in my opinion, is not good procurement practice. And at the same time, any partner is only as good as their last job. As soon as a study doesn’t go as planned, word gets around. Suddenly, you have teams questioning the CROs abilities and openly asking whether that CRO should perform their next study. When that talk spreads across the organization, it can ruin the vendor’s reputation. Throw in all of the consolidation we have been seeing, and it’s easy to understand why this is a difficult business for service companies to operate in.

Miseta: For a service provider that is not a strategic partner but would like to do business with you, what are the criteria you would look at?

Tandon: I think that has more to do with capabilities than anything else. To give you one example, in pharma I think eSource will soon completely change the way in which we capture data. Right now, there are just a few partners qualified to provide eSource technology (direct source data capture). This will lead to faster data capture, rapid data cleaning, and rapid output. As a medical director in an early phase study, you will be able to make dose escalation decisions early on. Companies that can help us launch those types of technologies, which will lead to faster and more efficient trials, are ones I am willing to talk to.